Impact of Physical Activity on Left Ventricular Mass and Lipid Metabolism

This study is currently recruiting participants.
Verified July 2013 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01199211
First received: September 9, 2010
Last updated: July 8, 2013
Last verified: July 2013

September 9, 2010
July 8, 2013
February 2011
June 2015   (final data collection date for primary outcome measure)
Lipid Metabolism [ Time Frame: Baseline, In-Training, Post-training (at least 6 weeks after the race) ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT01199211 on ClinicalTrials.gov Archive Site
Heart architecture and function [ Time Frame: Baseline, In-training, Post-training ] [ Designated as safety issue: No ]
Not Provided
Not Provided
Not Provided
 
Impact of Physical Activity on Left Ventricular Mass and Lipid Metabolism
Impact of Physical Activity on Left Ventricular Mass and Lipid Metabolism in Healthy Female Volunteers Training for a Marathon

Prospective study on the structural and functional changes in the heart of adult women assessed by echocardiogram and in lipid metabolism that occur in response to physical training. Using echocardiogram we will characterize the early determinants of "athletic remodeling". We will also assess the effect of intense physical training on lipid metabolism, focus on HDL subspecies and function.

Left ventricular hypertrophy, defined as an increase in the mass of the left ventricle may occur as a physiologic response to exercise (athletic remodeling aka "athletic heart"), but is most frequently encountered as a pathological manifestation of cardiovascular disease. The early determinants of athletic remodeling in the general population are largely unknown. In order to longitudinally explore the early determinants of athletic remodeling, we will recruit from the community, physically untrained women who have volunteered to run a marathon. We will prospectively assess left ventricular mass and function by echocardiogram during three consecutive stages/visits:

  • Baseline: prior to starting intense physical training
  • Trained: at the end of at least 12 week training period, prior to running the marathon.
  • Post-marathon: 6 weeks after running the marathon.

In addition, exercise impacts lipid metabolism and short-term exercise is known to increase HDL levels in plasma. Human HDL is structurally heterogeneous, comprising at least sixteen discrete species. It has multiple functions, pertinent to cardiovascular medicine such as the ability to accept effluxed cholesterol from the artery wall, culminating in sterol uptake in the liver. This "reverse cholesterol transport pathway" is thought to prevent the accumulation of cholesterol in the artery wall. We will assess the clinical and genetic determinants of the HDL response to physical exercise.

Observational
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Plasma

Non-Probability Sample

Community sample. Participants will be recruited by invitation to volunteer in the study.

Left Ventricular Hypertrophy
Other: Exercise training, women, marathon
Prospective study with no intervention in women who have volunteered to run a full marathon or a half-marathon. Each subject will serve as own control. Each subject will be studies at 3 stages: baseline, after at least 12 weeks of training for the marathon (we will not provide training), 6 weeks after running the marathon.
Exercise training, women, marathon.
Other: prospective study with no intervention
Intervention: Other: Exercise training, women, marathon
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
January 2016
June 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Healthy premenopausal adult women, aged 18 years or older
  • Voluntarily signed up to run a marathon or a half marathon for the first time
  • Normal to mildly elevated blood pressure (systolic blood pressure < 140 mmHg and/or diastolic blood pressure < 90 mmHg)
  • Hormone replacement therapy and birth control pills are allowed, provided they have been on a stable dose for more than 3 months and no change in dose is planned for the duration of the study
  • Capable and willing to provide written, informed consent for the study

Exclusion Criteria:

  • Post menopausal (last period more than one year ago)
  • History of cardiovascular disease (cardiomyopathy, heart failure, ischemic heart disease, stroke, TIA, peripheral vascular disease)
  • Change in body weight more than 10% over the past year
  • History of significant medical conditions, including respiratory, gastrointestinal, neuromuscular, neurological or musculoskeletal problems interfering with exercise.
  • Autoimmune or collagen vascular diseases, chronic anemia,
  • Malignancies in the past 5 years, with the exception of treated skin or breast cancer that did not require treatment with chemotherapy.
  • Diabetes
  • Pregnancy or recent delivery: delivery date less than 3 months prior to enrollment
  • Lipid lowering medications (statins, niacin, resins)
  • Fish Oil supplements are allowed, provided dose has been unchanged for 3 months prior to enrollment and no change in dose is planned for the duration of the study.
Female
18 Years to 55 Years
Yes
Contact: Eveline Oestreicher Stock, MD 415-476-1155 eoestreicher@medicine.ucsf.edu
United States
 
NCT01199211
CTSI-6212
Yes
University of California, San Francisco
University of California, San Francisco
Not Provided
Principal Investigator: Elyse Foster, MD University of California, San Francisco
Principal Investigator: John Kane, MD University of California, San Francisco
University of California, San Francisco
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP